JP3357079B2 - Left ventricular access lead for heart failure pacing - Google Patents

Abstract

An elongated monopolar or bipolar coronary vein lead having a reduced outer diameter and especially adapted to be advanced into a selected coronary vein for delivering a pacing signal to a predetermined region of a patient's heart, such as the left ventricle. A method of using the lead for pacing a patient's heart in the treatment of heart failure is also described. The method for pacing the heart includes advancing the coronary vein lead through both the coronary sinus and into a selected coronary vein of a patient's heart, connecting the lead to an electrical pacing source and applying electrical stimulation to a particular chamber of the patient's heart via the implanted lead. The lead includes a flexible tip and transition ring that enhances the ability to guide the lead through the coronary veins.

Description

BACKGROUND OF THE INVENTION I. Field of the Invention The present invention generally relates to electrical cardiac pacing and / or sensing leads, and the hemodynamic performance of diseased hearts using such leads. Optimizing the treatment of heart failure. In particular, the invention relates to an elongated flexible lead having a laser band electrode surface for placement in a selected coronary vein. The lead may include a transition ring to further assist the user in guiding the lead through the coronary vein. Also provided is a method of stimulating the left ventricle without delivering the lead to a predetermined area of the patient's heart and then implanting the pacing lead in the left ventricle.

II. Discussion of Related Art Hitherto, intravenously inserted leads for implantable cardiac pacemakers have basically been used to pace the right atrium and / or right ventricle, respectively, in the right side of the patient's heart. It has been placed in the atrium or right ventricle. Although it is relatively safe to insert pacing leads and associated electrodes into the right atrium or right ventricle, there was resistance to placing similar leads in the left ventricle. This is because a clot is formed and may cause seizure.

Whenever a lead is implanted in a patient's circulatory system, a thrombus can form and be released. When the lead is placed in the right atrium or ventricle, the resulting thrombus travels through the pulmonary artery and tends to be filtered in the patient's lungs. However, thrombus formation in the left atrium or left ventricle is dangerous for the patient because it can lead to the development of ischemia.

Therefore, where it is desirable to stimulate the left heart, it has been common practice to use an intercostal approach using leads that are screwed into the myocardium and actively fixed. However, screwed leads can cause trauma to the patient. Other pacing of the left ventricle may be desirable, such as during biventricular pacing. Mower, in U.S. Patent No. 4,928,688 (the "'688 Patent"),
To acquire coordinated contraction and pumping activity of the heart,
An arrangement is described that achieves biventricular pacing by applying a pulse that provides electrical stimulation to both the right and left ventricles with electrodes attached to a single pacing lead. The '688 patent discloses a split pacing lead having first and second independent electrodes, wherein the first
Preferably, an electrode is introduced into the superior vena cava for pacing the right ventricle and a second electrode is introduced through the coronary sinus for pacing the left ventricle. The lead and method described in the '688 patent are limited to placing the second electrode in the coronary sinus. Accordingly, there is a need for a lead having a structure suitable for placement in a coronary vein, including the posterior vein, central vein, or vena cava.

Other electrode leads are described for insertion into the coronary sinus. For example, U.S. Pat.No. 5,014,696 attributable to Mehra
And U.S. Patent No. 4,932,407 to Williams, disclose an endocardial defibrillation electrode system. Each of these discloses transvenous insertion of an electrode lead into the coronary sinus and vena cava of the patient's heart, but in each case, the lead may extend through the vena cava and descend to the apex of the heart. Absent. The leads disclosed by Mehra and Williams are limited to use with another lead inserted into the right ventricle or a large subcutaneous surface patch electrode to provide a defibrillation shock to the patient's heart.

Leads and methods suitable for pacing the left ventricle of a patient's heart according to the present invention are not disclosed in the related art. Related techniques can be used to improve synchronization and / or coordination of heart chamber contractions or to pace all four heart chambers with two leads so that the leads are placed in selected coronary veins. No lead wire having a laser band electrode surface is described. Also, current leads cannot be easily rotated and guided into the patient's coronary vein. Accordingly, there is a need for a lead and method for pacing a patient's heart and achieving the desired synchronization, where the lead is of a diameter, flexible, suitable for placement in any of several coronary veins. Chips,
And physical and rotational properties, which allow for selective pacing of the left ventricle, left atrium, right atrium, right ventricle, or a combination thereof. The present invention addresses these needs and overcomes other disadvantages of the prior art.

According to the present invention, the left ventricle or left atrium is selectively placed in any one of several coronary veins, thereby eliminating the need to place a pacing lead in the selected ventricle or atrium. A coronary vein lead is provided that can be selectively paced or detected. The coronary venous lead includes an elongated body, a flexible tip, a plurality of electrode surfaces, and conductors that couple the electrode surfaces to terminal pins.

The coronary venous lead may receive a stylet or guidewire in a hole formed along the central longitudinal axis of the lead. The lead may further include a flexible tip and a transition ring at a distal portion of the lead, which assists a user in guiding and rotating the lead into the coronary vein. Methods of placing a coronary venous lead at a desired location within a preselected coronary vein include the use of guide catheters, guidewires and support catheters.

Patients with heart failure have a need for pacing leads and methods that improve the synchronization and / or coordination of heart chamber contractions. Improved coordination can be achieved by simultaneous or differential coordination of the left ventricle with respect to synchronization or intrinsic contraction of the right ventricle, or with respect to synchronization / intrinsic contraction of the right or left atrium as well as the right ventricle.

Improvements in intrinsic contraction coordination of the heart can also be achieved by simultaneously or differentially pacing multiple locations of the left ventricle to optimize left ventricular contraction relative to other chambers. A preferred embodiment of the present invention comprises placing the lead of the present invention through the coronary sinus and placing the lead in the coronary vein;
Place one electrode surface on the anterior coronary vein near the apex of the left ventricle,
Aligning the second electrode surface inside the coronary sinus entrance near the left ventricular base.

Using a suitable pacemaker of known construction and a right ventricular lead, the coordination of the right and left hearts first paces the apex of the left ventricle and then delays (about 0-50 milliseconds) a delay. Later, it is achieved by stimulating the right and left ventricular bases. This pacing method demonstrates that the lead and patient heart pacing method according to the present invention achieves the desired synchronization. Where the leads are
The lead is placed in any of several coronary veins and has a diameter suitable for rotation and physical properties such as a flexible tip and a transition ring, which allows the left ventricle, left atrium, or left Selectively pace multiple locations in the atrium or left ventricle.

In the pacing method according to the present invention, a surgeon first inserts a guide catheter through the coronary sinus. Once the guide catheter is positioned in the coronary sinus, the coronary venous lead of the present invention is inserted through the guide catheter into the coronary vein associated with the desired heart chamber to be paced. The coronary vein lead preferably includes a stylet or guidewire hole that is removed from the coronary vein hole once the electrode of the lead wire is properly positioned adjacent the predetermined core.

Alternatively, the surgeon can insert a guide catheter through the superior vena cava into the mouth of the coronary sinus. next,
A guide wire is inserted into the guide catheter and advanced to the desired location within the preselected coronary vein. guide·
Once the wire is in place, the thin supporting catheter is advanced over the guide wire to the distal end of the guide wire. The guide catheter and guide wire are then removed, leaving the support catheter in place. next,
The coronary venous lead of the present invention is advanced through the support catheter to the desired location in the coronary vein. A flexible stylet or guidewire within the coronary venous lead provides it with axial stiffness as the lead is advanced through the support catheter. Once the coronary venous lead is in place, a stylet is used to maintain the lead in the coronary vein as desired as the support catheter is withdrawn or stripped from the lead body.

The coronary venous lead can be constructed according to any of several embodiments, wherein the outer diameter of the coronary venous lead is between .023 inches and .092 inches (about 2-7 French /
5.8 to 23.4 mm). The coronary venous lead preferably includes a plurality of longitudinally spaced electrode surfaces,
Thus, properly aligned leads can be used to pace or detect, for example, the left atrium, left ventricle and right atrium from more optimally positioned electrodes. By providing several electrode surfaces at the distal end portion of the lead, the surgeon can use a pacemaker programmable switch to apply a particular electrode, for example, for monopolar pacing of the left ventricle or a specific pair of bipolar pacing. You can select and optimize the contraction of the heart.

The transition ring can be located in the hole near the distal end of the coronary venous lead. The transition ring is
A slot or mating blade formed on the outer surface of the guidewire or other geometry to receive the geometry, thereby allowing the surgeon to rotate the proximal end of the guidewire to rotate the leadwire. To help rotate the distal end of the After removing the stylet, remove the guide catheter. The operator can then insert and place another coronary vein lead, depending on the desired pacing or detection mode. The terminal end of the coronary venous lead is then coupled to a cardiac pacemaker, so that paced pulses can be delivered to the patient's corresponding heart chamber.

A flexible tip may be formed at the distal end of the lead to further assist the patient in guiding the lead through the coronary vein. The flexible tip may include a sheath with a biomedical steroid impregnated in the sheath to mitigate the inflammatory response of the patient's heart tissue to the presence of the flexible tip. The tip can further be constructed to include an inner cylindrical cable mesh surrounded by an outer sheath, the cable mesh designed to provide stability and flexibility to the round tip.

Accordingly, it is a primary object of the present invention to provide an apparatus and method for pacing a patient's preselected heart chamber from a novel lead placed in a coronary vein.

It is another object of the present invention to provide a lead having a plurality of electrode surfaces and use of the lead for pacing the left ventricle from a coronary vein of a patient's heart.

It is yet another object of the present invention to provide an apparatus and method for pacing the left ventricle at various locations relative to the apex of the heart, thereby optimizing the left ventricular pacing of the patient's heart.

It is yet another object of the present invention to pace the left ventricle in several places, simultaneously or sequentially, in concert with right ventricular stimulation,
An object of the present invention is to provide a rotating flexible tip lead having a laser band electrode surface and a method of using the lead to improve the contraction of the right and left hearts.

The above and other objects, features and advantages of the present invention will become readily apparent to those skilled in the art from a consideration of the following detailed description of the preferred embodiments, taken in conjunction with the accompanying drawings. In the drawings, like numbers refer to corresponding parts.

DESCRIPTION OF THE DRAWINGS FIG. 1 is an enlarged partial perspective view of a coronary vein lead having one electrode.

FIG. 2 is an enlarged partial cross-sectional view of a lead of the type of the present invention having a coiled conductor in the lead hole.

FIG. 3 is an enlarged partial longitudinal sectional view of an alternative coronary venous lead having an outer diameter of about 0.023 inches (5.8 mm).

FIG. 4 is an enlarged partial cross-sectional view of a coronary vein lead of the present invention having a laser band conductor coil electrode.

FIG. 5 is an enlarged partial cross-sectional perspective view of an alternative coronary vein lead of the present invention having five ring electrodes.

FIG. 6 is a cross-sectional view taken along line 6-6 of FIG.

FIG. 7 is an enlarged partial cross-sectional perspective view of an alternative coronary vein lead of the present invention having five electrodes.

FIG. 8 is a cross-sectional view taken along line 8-8 of FIG.

FIG. 9 is an enlarged partial perspective view of an alternative tapered coronary venous lead of the present invention having three electrodes.

FIG. 10 is an enlarged partial cross-sectional side view of a tapered portion of a coronary vein lead of the type shown in FIG. 9, showing the transition ring disposed within the tapered portion.

FIG. 11 is an end view of a transition ring of the type shown in FIG.

FIG. 12 is an enlarged partial cross-sectional side view of an alternative embodiment of the flexible wire tip of the present invention.

FIG. 13 is a perspective view of the coronary vein lead of the present invention shown positioned within the anterior cardiac vein of the patient's heart.

FIG. 14 is a perspective view of the coronary vein lead of the present invention shown positioned within the posterior cardiac vein of a patient's heart.

FIG. 15 is a partial cross-sectional perspective view of the coronary vein lead of the present invention shown in the anterior cardiac vein and the right ventricular lead shown in the right ventricle.

FIG. 16 is a flowchart illustrating a method of pacing a patient's heart with a coronary venous lead.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring first to FIGS. 1 and 2, pacing the left ventricle from one of the posterior, central, or large veins of the heart, particularly for use with a cardiac pacemaker. A coronary venous lead 10 designed as such is shown. The coronary vein lead 10 has an elongated main body
12, rounded tip electrode 14, conductor 16, and terminal pin 18
including. Elongated main body 12 has a proximal end 20, a distal end 22, and a hole 24 extending longitudinally therethrough. Body 12
Is preferably formed from a medical grade polymer material such as silicone rubber, but is not limited to this particular material. Without limitation, the main body has a thickness of .004-.010 inches (0.1-.25 mm),
As a result, the outer diameter of the main body 12 is 0.023 to .092 inches (5.8 to 23.
4mm).

As can be seen in FIG. 3, the outer layer or sleeve 34
You may enclose 12. The sleeve 34 is made of carbon-coated silicon, steroid-eluting silicon,
Or it can be constructed from a combination of silicon and a fibrosis resistant surface treatment element. All of these components help mitigate tissue response to lead insertion,
Thus, the lead does not cause adhesion to the clot or venous wall, which allows the lead to be retracted if necessary in the future. This composition also helps prevent electrode encapsulation, thereby improving the effectiveness of the pacing and sensing functions.

Referring again to FIGS. 1 and 2, the conductor 16 is spirally wound and secured in a longitudinal hole 24 in the body 12. The distal end 26 of the conductor 16 is attached to the round tip electrode 14 and the proximal end is attached to the terminal pin 18 by swaging or welding as is well known in the art. Without any limitation,
Chip electrodes 14 and terminal pins 18 of known structure are manufactured from titanium or platinum-plated titanium. The conductor 16
It is preferred to have a conductive cable dip-coated or spray-coated with a polymer such as polytetrafluoroethylene, but is not limited to this particular material. The manufacture and construction of conductive cables is described in U.S. Pat.
No. 4,559,951, the disclosure of which is incorporated herein by reference in its entirety. The coated conductor has an outer diameter of .004 to .005 inches (.10 to .13 mm) and is spirally wound. hole
30 is formed within the spiral wound conductor 16 and has an inside diameter of .007 to .020 inches (.18 to .51 mm) and an outside diameter of .006 to .018 inches (.15 to .46 mm) A stylet 32 of known construction (shown in FIG. 4) is placed in the hole 30.

In the embodiment shown in FIG. 3, a helically coiled conductor 16 is embedded in a .001 inch (.25 mm) thick polymer body 12, thereby eliminating the need to coat the conductor.
The body has a center hole with an inside diameter of .007 to .020 inches (.18 to .51 mm) and an outer sleeve 34 surrounds the body 12. A stylet 32 (shown generally in FIG. 4) is disposed within the central hole of body 12 and is intended for use as an angioplasty guidewire.

4 and 5 show a preferred embodiment of the coronary venous lead 10. FIG. This embodiment includes a body 40, a longitudinal sleeve 42, a helically coiled conductor 44, and a tip 50. The lead wire 10 has a stylet 32 (as described above) that aligns with a vertical hole 52 formed by a spiral coiled conductor 44.
Is shown having a distal end portion. The distal end of the conductor 44 extends to the round tip 50, and the proximal end connects to a terminal pin of known construction.

A window 56 is formed in the body 40 and sleeve 42 of the lead adjacent the central portion of the conductor 44 near the distal end of the body 40. The conductor coils 44 exposed in the window 56 are fused or melted together by a laser or other known means to create an electrode surface 54. One skilled in the art will be aware of U.S. Pat.No. 4,559,951.
As described in US Pat.
Although incorporated herein by reference, laser band electrode surfaces are preferred.

As described above, the conductor 44 may be embedded in the body 40. Although not limited, the outer diameter of the main body 40 is .023 to .0
It may be 92 inches (.58-2.3 mm) and the wall thickness of the cylindrical wall of body 40 is .007-.010 inches (.18-2.5 mm). In the embodiment shown in FIGS. 4 and 5, the window 56 and the exposed electrode surface
54 is spaced a predetermined distance from the distal end of the lead, thereby positioning the lead 10 after placing the lead 10.
Aligns with a coronary vein adjacent to a predetermined portion of the left ventricle.

One skilled in the art can use an electrode tip in place of the tip 50 and place the tip at the distal end of the lead to separate the electrode tip into a separately insulated conductor coil coiled with the conductor coil 44. It will be appreciated that the mounting, which allows the electrode surface 54 to be positioned near the tip electrode, and thus the electrode can be used for sensing or bipolar pacing. The pacing signal can then be sent to the electrode surface 54 and the tip electrode simultaneously or sequentially. Or,
It completely eliminates the tip electrode, thus allowing for monopolar pacing between the electrode surface and the pacemaker. In such a case, the tip 50 can be provided with a continuous insulating polymer, carbon-coated silicone polymer or other fibrosis resistant mounting surface treatment, thereby encapsulating the distal end of the body 40 and the conductor coil 44.

Referring now to FIGS. 6 and 7, a coronary venous lead is shown.
Ten other embodiments are illustrated. In this embodiment, five independently insulated conductors 60-68 are shown spirally coiled and extend through holes 72 in body 70. Each conductor 60-66 is coupled to a corresponding electrode ring 74-80 (as described above), and conductor 68 is coupled to a round tip electrode 82. In the embodiment shown in FIGS. 8 and 9, the insulated conductors 60-68 are coiled helically and embedded in the body 70, with the central longitudinal hole 72 in the stylet 32.
You can see that they are receiving

FIG. 10 shows an alternative coronary venous lead 10 having a tapered body 90 (tapered parts are exaggerated).
90 tapers near the distal end of body 90 and decreases in diameter. A tapered ring electrode 92 corresponding to the taper of the body 90 and
Along the taper near the distal end of the body 90,
Molded into. Conductors 96 and 98 linking electrodes 92 and 94 to terminal pins of known construction
The coil is wound spirally within 90.

FIG. 11 is a cross-sectional view of a lead of the type shown in FIG. 10, showing the transition ring 100 crimped or welded to the conductors 96 and 98 and positioned within the taper. The transition ring 100 includes a slot 102 formed at its proximal end and a hole 104 extending along its longitudinal axis (see FIG. 12). The stylet or guide wire used to guide the lead (as described above) has a smaller diameter area that extends through hole 104 in transition ring 100 to the tip of the lead. When the styler's stiffer, larger diameter section is flattened along a portion and the stylet is fully inserted into the lead hole, it aligns with the slot 102 in the transition ring 100, and the mating blade Can be formed. By rotating the proximal end of the stylet, the surgeon can rotate and manipulate the distal end of the lead, thereby improving the maneuverability of the smaller taper of the lead 10.

Those skilled in the art will appreciate that the transition ring 100 can be located near or proximal to the proximal end of the lead 10. Placing the transition ring 100 close to the distal end of the lead wire 10 allows for better control of the tip position. Alternatively, the slot 102 formed at the end of the transition ring 10 can take any of a number of geometrically shaped sockets, such as a square, triangle, or hexagon. Thus, the transition ring of the present invention may also be located at the distal end of a lead of known construction, thereby increasing the ability to guide the lead.

FIG. 13 is yet another embodiment of a lead 10 having a ring electrode and suitable for placement in a coronary vein. Lead
10 has a body 120, a hole 124, a conductor 126, and a wire mesh 128 attached to and extending from the distal end of the electrode 122. A round flexible tip 130 surrounded by a wire mesh 128 is formed by an outer flexible polymer sheath. The sheath has a biomedical steroid impregnated in the sheath to reduce the inflammatory response of the patient's heart tissue to the presence of the flexible tip. The wire mesh 128 is cylindrical in shape and is designed to provide stability and flexibility to the round tip. Referring to FIG. 11, a similar flexible tip is illustrated, wherein the conductor 98 extends distally from the ring electrode 94. In this configuration, the conductor 98 is surrounded by the impregnated polymer flexible tip 130 and replaces the wire mesh 128, providing stability and flexibility to the round tip 130.

14 to 16 show the placement of a coronary vein lead in a patient's coronary vein for various pacing. FIG. 14 shows a coronary vein lead 10 similar to that shown in FIG. 4, with the distal end and round tip 50 aligned with the left ventricle (located in the anterior cardiac vein) and a laser band electrode 54. Aligns with the left atrium. Lead 10 is connected to a cardiac pacemaker (not shown) for independently pacing the left ventricle. FIG. 15 shows a coronary vein lead 10 similar to that shown in FIGS. 6 and 7, with the distal end of the tip electrode 82 aligned with the left ventricle (disposed in the posterior cardiac vein) and the electrode ring
76 is aligned with the left atrium. Lead 10 is connected to a cardiac pacemaker (not shown) for independently pacing the left ventricle and left atrium. FIG. 16 shows a coronary vein lead 10 similar to that shown in FIGS. 11-12 or 13;
The distal end of the round flexible tip 130 is aligned with the left ventricle (located in the anterior ventricle), the first electrode 92 is aligned with the left atrium, the second electrode 94 is aligned with the left ventricle, and the second electrode 94 is aligned with the left ventricle. A lead 210 extends into the right ventricle. The leads are connected to a cardiac pacemaker (not shown) to independently pace the left ventricle, left atrium and right ventricle. Of course, a third electrode could be placed on the lead to align with the right atrium and pace the left ventricle, left atrium, right ventricle and right atrium independently.

Having generally described the features and arrangement of the coronary venous lead 10, various methods of pacing a patient's heart using the coronary venous lead 10 will now be described with reference to the flowchart of FIG. consider. The method of pacing the patient's heart identified in the flowchart of FIG. 17 allows the user to effectively pace the left ventricle without increasing the risk of developing ischemia.

The operator first places a strippable guide catheter known to those skilled in the art into the coronary sinus (block 150). Although a guide catheter is not absolutely necessary, a guide catheter enhances the operator's ability to properly place the coronary vein lead 10 into a preselected coronary vein. Once the guide catheter is placed in the coronary sinus, the coronary venous lead 10 is passed through the hole in the guide catheter and inserted into a given coronary vein while observing with a fluoroscope (see block 152). A coronary vein lead 10 is placed in the selected coronary vein and the electrodes of the coronary vein lead 10 align with the heart chamber selected for pacing. Those skilled in the art will appreciate that the electrodes can be constructed from a radiopaque material so that the location of the electrodes can be easily determined. Once the coronary venous lead 10 is in place, the stylet or guide wire (if any) is disconnected from the coronary venous lead (block 154). The catheter is then removed from the coronary sinus (block 15).
6) This causes the catheter to be torn off as the catheter is withdrawn from the terminal pins of the coronary venous lead 10. As mentioned above, the guide catheter is
A guide wire can be used to guide the support catheter to the desired location within a given coronary vein. Next, the coronary vein lead 10 is placed using the indicating catheter as described above.

After removing the guide catheter, the operator
It is determined whether there are additional coronary vein leads to be inserted and placed in the coronary vein of the patient's heart (decision block 158). If another coronary vein lead 10 is to be placed in a preselected coronary vein, the above steps represented by blocks 150-156 are repeated (see loop 160). One skilled in the art will appreciate that additional leads of appropriate construction can be placed in the right ventricle. If there are no other coronary vein leads 10 to be inserted and placed, the terminal pins 18 attached to each coronary vein lead 10 are coupled to the corresponding terminal portions of the cardiac pacemaker (block 162). Next, the cardiac pacemaker is programmed by known means and a pacing pulse is transmitted through each associated coronary venous lead 10 (block 164), thereby pacing the preselected heart chamber of the patient's heart.

Once the coronary vein lead 10 (of a suitable embodiment) has been inserted and deployed, the operator may, for example and without limitation, pace or detect both the left atrium and left ventricle, or And the ability to pace or detect the right atrium. The placement of a separate right ventricular lead allows pacing and / or detection of the entire chamber. The diameter and configuration of the coronary venous lead provides the necessary flexibility to substantially eliminate the potential for the bent coronary venous lead 10 to erode through the coronary vein. At this point, the body 12 of the coronary vein lead 10 is coated or impregnated with a biomedical steroid to reduce the inflammatory response of the coronary vein to inserting and placing the coronary vein lead 10 in the coronary vein. be able to. The selected biomedical steroid can also be used to reduce the amount of fiber that accumulates between the coronary vein lead 10 and the coronary vein. Coronary venous lead 10 can be constructed to include an anchoring member, thereby securing lead 10 in a coronary vein or coronary sinus.

The present invention has been described in considerable detail in order to comply with patent laws, apply new principles to those skilled in the art, and provide the information necessary to construct and use the specific components as required. Have been. However, it should be understood that the invention can be practiced with distinctly different equipment and devices, and that various changes can be made in both the device and the operating procedures without departing from the scope of the invention itself.

────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Tokman, Bruce A. United States 55073, Pondroy Avenue, Scandia, Minnesota 21788 (72) Inventor Hale, Ronald W. Bruce. Junia. United States 55113 Roseville, Minnesota, Western Avenue North 2312 (72) Inventor Westlund, Randy United States 55407 Minneapolis, Minnesota, Sixtys Avenue South 2618 (72) Inventor Chastin, Stuart Earl. United States 55126 Minnesota Shoreview, Chatsworth Street 3430 (56) References JP-A-6-218064 (JP, A) JP-A-58-192206 (JP, A) JP-A-2-307482 (JP, A) JP-A-3-3 170171 (JP, A) JP-A-55-94265 (JP, A) JP-A-57-70343 (JP, U) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61N 1/368 A61N 1 / 05

Claims (12)

(57) [Claims] 1. An elongated coronary vein lead for delivering a pacing signal and detecting an electrical impulse at a predetermined region of a patient's heart, comprising: a) an elongate, flexible, proximal and distal end; A body portion, the majority of which is an insulating body portion of uniform diameter, the distal end having a round tip attached thereto, the body portion tapering at a transition region following the distal end; b) a plurality of electrodes insulated from each other and spaced apart from each other by a predetermined distance and embedded in said body portion; c) a plurality of independently insulated conductors, the distal end of each conductor comprising: Independently attached to a corresponding one of the plurality of electrodes, a proximal end of each conductor is attached to a corresponding terminal pin, and the plurality of independently insulated conductors are disposed within the elongated body portion. The center hole wound in a spiral coil And d) a transition ring fixed in the center hole in the transition portion at a predetermined distance from the distal end of the lead wire, the transition ring having a non-through groove at a proximal end thereof. E) elongated guide means for guiding the lead through the patient's heart, said guide means comprising a ridge interengaging with a non-through groove of the transition ring; Guide means removably disposed within the central bore to facilitate guidance of the tapered distal portion of the lead body into the vein. 2. The method of claim 1, further comprising a sleeve surrounding the body, the sleeve having a biomedical steroid impregnated in the sleeve to mitigate an inflammatory response of the patient's heart tissue to the presence of the lead body. The lead according to claim 1. 3. The lead of claim 1, wherein said body has an outer diameter in the range of 0.023 to 0.09 inches. 4. The lead of claim 1, wherein said transition ring includes a slot for interengaging a blade formed on said guide means. 5. The lead of claim 1, wherein the round tip is formed around a cylindrical cable mesh to provide stability and flexibility to the round tip. 6. The lead of claim 1, wherein the round tip is formed from a flexible polymer. 7. The lead of claim 1, wherein one of the plurality of independently insulated conductors extends to a distal end of the body, thereby forming a round tip. 8. An elongated coronary vein lead for delivering a pacing signal at a predetermined region of a patient's heart and detecting electrical impulses at a predetermined region of the patient's heart, comprising: a) a proximal and distal end. An elongated, flexible, mostly insulated body portion of uniform diameter, the distal end having a round flexible tip attached thereto, the body portion being a transition region following the distal end A) a body portion tapering at; b) an insulated conductor helically coiled within the elongated body to define a central hole; c) the body having a window formed in the body; A portion of the conductor is exposed through the window of the body, the exposed portion is melted to form an electrode surface; d) the center within the transition region a predetermined distance from the distal end of the lead. A transition ring fixed in the hole. A transition ring provided with a non-circular non-through groove at a proximal end of the transfer ring; and e) elongate guide means for guiding a lead through a patient's heart, said guide means comprising: With a ridge that interengages with the non-penetrating groove of the lead body and is removably disposed within the central hole to facilitate guiding of the tapered distal end of the lead body portion to a given coronary vein. And a guide means. 9. A biomedical device impregnated in said sleeve to mitigate an inflammatory response of a patient's heart tissue to the presence of a lead body, said sleeve further comprising a sleeve surrounding a predetermined portion of said body. 9. The lead according to claim 8, comprising a steroid. 10. The lead of claim 8, wherein said body has an outer diameter in the range of 0.023 to 0.092 inches. 11. The lead of claim 8, wherein said transition ring includes a slot for interengaging a blade formed on said guide means. 12. The round flexible tip further includes a biochemical steroid impregnated sheath to mitigate an inflammatory response of the patient's heart tissue to the presence of the flexible tip. Enclosed internal cylindrical cable
9. The lead according to claim 8, including a mesh, wherein the cable mesh is designed to provide stability and flexibility to a round tip.